Development of Melt Organic Baking Fat for Reducing Child Obesity

Not Applicable

Completed

• Conditions: Obesity; Overweight; Pediatric Obesity
• Interventions: Dietary Supplement: Corn Oil; Dietary Supplement: Melt Test Blend 3.2

• Registration Number: NCT02346994
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.

Detailed Description

The overall objectives of this study are to determine whether a Melt Organic baking blend can alter energy balance towards a negative energy balance by enhancing thermic effect of food and improving feelings of satiety relative to a control, corn oil, in overweight and obese adolescents.

This study will employ a 2-arm, double-blind, randomized, crossover design. Each arm will consist of one test day and will differ in the type of oil incorporated in the test breakfast: test blend 3.2 or corn oil. Oil sequence will be randomized. Each test day will follow the same protocol and will be separated by at least two weeks for boys or 4 weeks for girls to ensure that testing occurs during the same phase of their menstrual cycle for each test day.

Participants will arrive at the testing center after an overnight 12-h fast. Upon arrival, body weight will be taken and a catheter will be inserted in an antecubital vein. The participant will then rest for 30 minutes, after which resting metabolic rate (RMR) will be measured using an indirect calorimetry cart. RMR will be measured over a 45-min period. At the end of the RMR measurement, a fasting blood sample will be obtained, and the participant will be given a standard breakfast (containing 20 g of fat from either test blend 3.2 or corn oil) to consume over a 10-min period. The fat in the breakfast will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal and the rest of the energy will be provided in the form of fat free yogurt, up to 140 kcal, and applesauce.

Following breakfast, postprandial energy expenditure will be assessed every hour using the indirect calorimetry cart. At each hour of this 5-h period, participants will fill out a visual analog scale to assess their feelings of appetite and satiety and will perform a computer task assessing prospective food intake. Immediately after breakfast, and at 30, 45, 60, 120, and 180 minutes after breakfast, a blood sample will be drawn from the catheter for metabolite and hormone measurements.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-27
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
• Weight stable (+/- 2.5 kg) for at least 3 months prior to screening

Read More

Exclusion Criteria

• Any endocrine disorder, including type 1 diabetes
• Weight loss attempted in past 3 months
• Currently using medication (prescription or over-the-counter) that could impact study outcomes
• Asthma
• Anemia
• Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
• Use of (current or in the past 4 weeks) any investigational medications or devices
• Allergy/sensitivity to wheat, milk, eggs, nuts

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Corn Oil	Corn Oil	-
Melt test blend 3.2	Melt Test Blend 3.2	-

Primary Outcome Measures

Name	Time	Method
Thermic effect of food	5.5 hours	An indirect calorimetry cart will measure energy expenditure for approximately 40 minutes out of each hour for 5 hours after breakfast.

Secondary Outcome Measures

Name	Time	Method
Appetite/satiety measures area under the curve	5.5 hours	A visual analog scale and a computer program will assess different aspects of appetite and satiety in study participants.
Insulin, glucose, triglycerides area under the curve	Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast	Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.

Trial Locations

Locations (1)

New York Nutrition Obesity Research Center; 🇺🇸 New York, New York, United States